BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSADIAL HEAD IMPACTOR

    MDR report key: 3782032 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03364
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWA
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A REVERSE SHOULDER HEMIARTHROPLASTY ON (B)(6) 2014. DURING THE PROCEDURE THE VERSADIAL HEAD IMPACTOR SPLIT DOWN THE MIDDLE. A PIECE OF THE INSTRUMENT FELL INTO THE PATIENT'S WOUND SITE AND WAS RETRIEVED. AN ALTERNATIVE IMPACTOR WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260173 VERSADIAL HEAD IMPACTOR IMPACTOR HWA BIOMET ORTHOPEDICS N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R